NCT07001462Completed
Effectiveness of IMT/PEP Therapy in Group E COPD and Comparison of GOLD vs STAR Classifications
Effects of Combined Inspiratory Muscle Training and Positive Expiratory Pressure Therapy on Pulmonary Function, Respiratory Muscle Strength, Exercise Capacity and Dyspnea in Stable Group E COPD Patients
Source: ClinicalTrials.gov · Last updated 24 Sept 2025
Brief summary (registry, in English)
Background: Inspiratory muscle training combined with positive expiratory pressure (IMT/PEP) may improve outcomes in chronic obstructive pulmonary disease (COPD), but evidence in exacerbation-prone (Group E) disease is limited. This study is designed to evaluate the effects of IMT/PEP on pulmonary function, respiratory muscle strength, exercise capacity, and dyspnea in stable Group E COPD. Methods : This prospective randomized controlled trial will enroll 62 patients with stable Group E COPD between June 2023 and September 2024. Participants will be randomized to receive IMT/PEP plus standard care or standard care alone. Pulmonary function tests, maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), six-minute walk test (6MWT), oxygen saturation (SO₂), and dyspnea scales (mMRC, CAT, MBS, VAS) will be assessed at baseline, 1 month, and 3 months.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 61 (actual)
- First submitted
- 24 May 2025
- Start date
- 1 Jun 2023
- Primary completion date
- 3 Feb 2024
- Lead sponsor
- Bugra Kerget
- Diseases
- COPD
- NCT number
- NCT07001462
What you commit to
- Study type: Observational
- Participants enrolled: 61
- From 1 Jun 2023 to the primary completion date, 3 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Contraindications to pulmonary function testing or 6-minute walk test (e.g., recent myocardial infarction, unstable angina)
- Inability to perform inspiratory or expiratory maneuvers reliably (e.g., due to cognitive or neuromuscular disorders)
- Any condition deemed by investigators to interfere with study participation
Other
- Acute exacerbation of COPD at time of enrollment
- Significant orofacial muscle weakness unresponsive to modified mouthpiece
- Participation in another interventional study within the past 3 months
- Nonadherence to COPD treatment plan
Who the study is looking for
- Age ≥ 40 years
- Diagnosis of Group E COPD according to GOLD 2023 criteria
- Post-bronchodilator FEV₁/FVC \< 0.70 and FEV₁ \< 50% predicted
- mMRC score ≥ 2 or CAT score ≥ 10
- History of ≥2 exacerbations or ≥1 hospitalization in the past year
- Stable clinical condition (no exacerbation in the past 2 weeks)
- Ability and willingness to perform IMT/PEP therapy
- Provided written informed consent
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atatürk University Coordinator of this site? Confirm its status | Erzurum | Turkey (Türkiye) | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.